510(k) Report

510(k) · Cleared

Cleared

MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine Coating

K033714510(k) SpecialCleared Dec 11, 200315-day reviewClass II21 CFR 870.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dideco S.P.A. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Dec 11, 2003 as substantially equivalent to K933481 (Sorin Biomedical, Inc., 1993) and 2 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1992.

Decided
Dec 11, 2003
Review
15 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K922933 (1992). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1995: 1 other ancestorK922933 · Sorin Monolyrh Integrated Membrane Lung · Sorin Biomedica, Fiat, USA, Inc. · 1992K980600 · D903 Avant Adult Hollow Fiber Oxygenator · Dideco S.P.A. · 1998K020351 · D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator · Dideco S.P.A. · 2002K022450 · Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy · Dideco S.P.A. · 2002K031223 · Synthesis Mimesys Adult Membrane Oxygenator · Dideco S.P.A. · 20031990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 1 other ancestor K031223 · Synthesis Mimesys Adult Membrane Oxygenator · Dideco S.P.A. · 2003K022450 · Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy · Dideco S.P.A. · 2002K020351 · D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator · Dideco S.P.A. · 2002K980600 · D903 Avant Adult Hollow Fiber Oxygenator · Dideco S.P.A. · 1998K922933 · Sorin Monolyrh Integrated Membrane Lung · Sorin Biomedica, Fiat, USA, Inc. · 1992−50
  1. Root · 5 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
  2. 4 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
  3. 3 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
  4. 2 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
  5. 1 generation backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
  6. This deviceK033714 MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with…Dideco S.P.A. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K922933Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc.1992—
−4K980600D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A.1998—
−3K020351D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A.2002—
−2K022450Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial…Dideco S.P.A.2002—
−1K031223Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A.2003—
0 (this device)K033714MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine…Dideco S.P.A.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199910
200120
FIG. 1 — Lineage of K033714, 1992–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DTN device

  1. #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K933481Sorin Monolyth Venous Reservoir
Summary page 1
…ION NAME: Reservoir, Blood Cardiopulmonary Bypass PREDICATE DEVICES: MVR 1200 Sorin Monolyth Venous Reservoir (K933481), SYNTHESIS Adult Membrane Oxygenator with Integrated…
Sorin Biomedical, Inc.1993—
*K022450Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…
Summary page 1
…Mimesys treated (Phosphorilcholine coating hereinafter called PC coating) (K022450), SYNTHESIS MIMESYS Adult Membrane Oxygenator with…
Dideco S.P.A.2002—
*K031223Synthesis Mimesys Adult Membrane Oxygenator
Summary page 1
…Reservoir Mimesys Treated (PC coating) including the CVR 1200 PC with PC coating soft shell reservoir (K031223). DEVICE DESCRIPTION: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorilcholine coating (hereafter referred to as the MV…
Dideco S.P.A.2003—

Also cleared against K933481: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8 months on median.
  • None of the 10 ancestors has a recall.
  • 1 other device also cites its predicate K933481.

How does its category compare?

All DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007: 22008: 12009: 72010: 12011: 22013: 42014: 32015: 22017: 22023: 12024: 22025: 1
2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2009: 211 days median2013: 79 days median2014: 38 days median
2007high 211 (2009) · low 38 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTN

2in 2018

2007: 12008: 12009: 12011: 12016: 12017: 12018: 2
2007high 2 (2018) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTN

8in 2025

2007: 102008: 82009: 102010: 182011: 102012: 172013: 472014: 522015: 272016: 62017: 32018: 42019: 112020: 62021: 122022: 72023: 82024: 102025: 8
2007high 52 (2014) · low 3 (2017)2025

MAUDE reports naming product code DTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—110
20081—18
20097211110
20101—018
20112—110
20120—017
2013479047
2014338052
20152—027
20160—16
20172—13
20180—24
20190—011
20200—06
20210—012
20220—07
20231—08
20242—010
20251—08
20260—0—

What is it indicated for?

The MVR 1200 PC is intended for use as a storage reservoir for blood in an extracorporeal bypass circuit for periods up to six hours.

Indications for use as stated in the FDA summary.

Also cleared against K933481

1 other device cites the same predicate.

  • K990103Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , CVR 600 and…Sorin Biomedical, Inc. · 1999

More from Dideco S.P.A.

22 FDA decisions under this applicant name. See the company

  • K041061D731 Micro 20 and D733 Micro 40 Pediatric Arterial FiltersDideco S.P.A. · 2004
  • K033323D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with…Dideco S.P.A. · 20041 recall
  • K033987D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
  • K032040Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult…Dideco S.P.A. · 20031 recall
  • K031223Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003

Recent decisions in DTN

The DTN category page

  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L. · 2024
  • K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™…Medtronic Cardiac Surgery · 2024
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  • K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

https://510kreport.com/device/K033714 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033714: MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033714

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026